better to have not been short AMGN from friday , and 3-M reported this am ...(i knew you weren't ;-)
FDA Approves Amgen's Aranesp(TM) For Anemia Associated With Chemotherapy
- New Anemia Treatment Joins Amgen's Neulasta(TM) to Simplify Supportive
Care for Cancer Patients Undergoing Chemotherapy -
THOUSAND OAKS, Calif., July 22 /PRNewswire-FirstCall/ --
Amgen (Nasdaq: AMGN), the world's largest biotechnology company, today
announced that the U.S. Food and Drug Administration (FDA) has approved
Aranesp(TM) (darbepoetin alfa) for the treatment of chemotherapy-induced
anemia in patients with nonmyeloid malignancies. Aranesp is a recombinant
erythropoietic protein (proteins that stimulate production of oxygen-carrying
red blood cells) that requires fewer injections than existing treatment.
Amgen revolutionized anemia treatment with the discovery of recombinant
human erythropoietin in 1984, which led to the development of Epoetin alfa,
currently marketed as EPOGEN(R)(i) and Procrit(R)(ii). Building on this
heritage, Amgen created Aranesp, which was developed to simplify anemia
management.
Aranesp maintains its level in the blood approximately three times longer
than Epoetin alfa, offering healthcare providers the ability to treat anemia
related to chemotherapy with less-frequent dosing than the current standard of
care.
Less-frequent dosing results in fewer injections for patients. It allows
patients and caregivers to spend less time scheduling injection visits, and
will free up physicians and nurses to attend to other patients and work
activity.
"Anemia can take a tremendous toll on patients undergoing chemotherapy,
often leaving them too weak to perform routine activities. In severe cases,
anemia can force doctors to interrupt chemotherapy regimens," said Robert E.
Smith, Jr., M.D., president of South Carolina Oncology Associates PA and an
Aranesp investigator. "Aranesp not only helps correct anemia and maintain
hemoglobin levels during chemotherapy, but also helps chemotherapy patients
and their physicians overcome barriers that can hinder the delivery of current
anemia treatment, notably the need for frequent office visits."
This year, an estimated 1.2 million cancer patients will undergo cytotoxic
chemotherapy in the United States; and approximately 800,000 (67%) will become
anemic. Anemia is the shortage of oxygen-carrying red blood cells that fuel
body function. Patients undergoing chemotherapy often suffer from anemia
because chemotherapy not only attacks cancerous cells, but other cells in the
body as well, including red blood cells. Aranesp(TM) stimulates the bone
marrow to increase the production of red blood cells and has been shown to
result in a clinically significant improvement of anemia associated with
chemotherapy. Before Aranesp, physicians were limited to treating anemia
associated with chemotherapy with frequent injections of Epoetin alfa or red
blood cell transfusions.
"Aranesp is an important development that will make it easier for
oncologists to treat their chemotherapy patients' anemia," said Amgen chairman
and chief executive officer Kevin Sharer. "Joining the once-per-chemotherapy-
cycle dosed Neulasta(TM) (pegfilgrastim), Aranesp's simplified dosing regimen
represents Amgen's next generation of powerful supportive care treatments for
patients receiving chemotherapy. With Aranesp and Neulasta, Amgen is helping
physicians, nurses and patients address two of the most serious complications
of chemotherapy."
Clinical studies showed that patients suffering from chemotherapy-related
anemia who received Aranesp consistently reached target hemoglobin (red blood
cell) levels. The studies showed Aranesp to be generally well-tolerated.
Aranesp was approved by the FDA in September 2001 for the treatment of
anemia associated with chronic renal failure, also known as chronic kidney
disease, for patients on dialysis and patients not on dialysis.
Aranesp is contraindicated in patients with uncontrolled hypertension.
Erythropoietic therapies may increase the risk of thrombotic and other serious
events; dose reductions are recommended if the hemoglobin increase exceeds 1.0
g/dL in any two-week period. The most commonly reported side effects in
Aranesp trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and
dyspnea; no important differences were observed between Aranesp and Epoetin
alfa.
Neulasta(TM) was approved by the FDA in January 2002 for decreasing the
incidence of infection as manifested by febrile neutropenia (neutropenia with
fever) in patients with non-myeloid malignancies receiving myelosuppressive
anti-cancer drugs.
In clinical trials, the most common adverse event attributed to Neulasta
therapy following combination chemotherapy in patients (n=465) with lymphoma
and solid tumors was bone pain, reported in 26% of patients. The only serious
adverse event not attributed to underlying disease or chemotherapy was a case
of hypoxia. While not reported in patients receiving Neulasta, rare events of
adult respiratory distress syndrome, splenic rupture, and sickle cell crisis
have been reported in patients receiving the parent compound, Filgrastim.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology. |
